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Medium risk Drugs & MedicationsClass II

Unichem Bisoprolol Hydrochlorothiazide Recall

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LT

Updated January 21, 2026

Unichem Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide 2.5 mg/6.25 mg tablets because the manufacturer detected that the drug may contain higher levels of a nitrosamine impurity (N-Nitroso Bisoprolol) than allowed by safety standards. Long-term exposure to elevated levels of this impurity may increase cancer risk.

Is the Unichem Pharmaceuticals USA Inc. recalled? Yes. This product was recalled by FDA on January 21, 2026. Details below.

What is recalled

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, NDC 29300-187-01, manufactured by Unichem Laboratories Ltd., Pilerne, Goa, India, and distributed by Unichem Pharmaceuticals USA Inc., East Brunswick, New Jersey.

Am I affected

You are affected if you have a prescription bottle labeled Bisoprolol Fumarate and Hydrochlorothiazide 2.5 mg/6.25 mg with NDC number 29300-187-01 on the label.

What to do right now

Stop taking this medication and contact your doctor or pharmacist immediately for a safe replacement. Do not dispose of the tablets without guidance from your pharmacist.

The hazard

CGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Brands affected

Unichem Pharmaceuticals USA Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0301-2026
Classification
Class II
Recalled
January 21, 2026
Read the official notice

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